FDA approves first Boniva generics to treat or prevent osteoporosis

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.

The most common type of bone disease, osteoporosis, is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures of the hip, spine, and wrist. Ibandronate is in a class of medications called bisphosphonates that help increase bone mass and reduce the chance of having a spinal fracture.

According to the National Institutes of Health, in the United States more than 40 million people either already have osteoporosis or are at high risk due to low bone mass.

"Men as well as women are affected by osteoporosis, a disease that can be prevented and treated," said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research. "For people who must manage their health conditions over time, it is important to have affordable treatment options."

Generic drugs approved by FDA have the same high quality and strength as brand-name drugs and provide a lower cost alternative. The generic manufacturing and packaging sites must pass the same quality standards as those of brand name drugs.

Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. are the manufacturers that have gained FDA approval to make generic 150 milligram ibandronate tablets.

An FDA-required Medication Guide will be given to patients and caregivers when ibandronate is dispensed, describes the risks and adverse reactions people should be mindful of when using the drug. Ibandronate can cause serious side effects including: esophagus problems; low calcium levels in the blood; bone, joint, or muscle pain; severe jaw bone problems; and unusual thigh bone fractures.

In the clinical trials for Boniva, the most commonly observed adverse reactions were: back pain, indigestion (dyspepsia), pain in extremity, diarrhea, headache, and muscle pain (myalgia).

Information about the availability of generic ibandronate can be obtained from the manufacturers.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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